Results in Coronary Bifurcation Lesions for Medtronic's Resolute Drug-Eluting Stent Presented at EuroPCR

May 22, 2013—Presented at EuroPCR 2013, held in Paris, France, three separate analyses demonstrated the performance of the Resolute drug-eluting stent from Medtronic, Inc. (Minneapolis, MN) in coronary bifurcation lesions over the long term.

Investigators pooled the results of nearly 3,500 real-world patients who received a Resolute stent as participants in two studies with very few exclusion criteria—RESOLUTE All-Comers and RESOLUTE International. From a total of 3,489 patients, 703 patients (20%) presented with at least one bifurcation lesion. At 3 years of follow-up, the Resolute drug-eluting stent showed no statistical differences between patients with and without bifurcation lesions. Rates of clinically-driven target lesion revascularization (ie, repeat procedure), for example, were low and comparable for both groups: 6.9 % versus 5.4% (P = .104), respectively.

In a separate, independent real-world multicenter registry that included nine sites in Italy, 527 patients with bifurcation lesions were treated with the Resolute stent using mainly the provisional T-stenting technique. Two-year follow-up results from this confirmatory study also showed low target lesion revascularization rates for these patients, at 5.1%. Of note, the long-term clinical outcome was similarly good across patients with different anatomical complexity of treated bifurcation lesions.

“Bifurcations remain a common challenge in today's practice due to anatomical variability and lesion complexity,” said Francesco Burzotta, MD, from the Catholic University of the Sacred Heart in Rome, who presented the results. “Nevertheless, the provisional T-stenting technique may be facilitated by specific technical characteristics of some contemporary drug-eluting stents. Results from multiple analyses demonstrate that use of the Resolute stent to treat bifurcated lesions may be associated with promising long-term clinical results in a wide variety of cases.”

In another EuroPCR presentation, Peter Mortier, PhD, from Ghent University in Belgium, shared the results of an independent analysis comparing different drug-eluting stent platforms in bifurcation lesions using computer models. This analysis found that the Resolute Integrity stent showed significantly less stent-strut malapposition (ie, lack of contact between stent struts and artery wall) compared to the Promus Element and Xience Prime stent platforms from Boston Scientific Corporation (Natick, MA) and Abbott Vascular (Santa Clara, CA), respectively.

Approved by the US Food and Drug Administration (FDA) in 2012, the Resolute Integrity stent is not indicated for the treatment of bifurcation lesions in the United States; its CE Mark labeling, however, does include an indication for bifurcation lesions, the company advised.